Physician - Associate Director

Job Description

• Medical Degree
• Medical training in TA
• Profound Therapeutic Area/Disease Knowledge, Pt journey
• Tx guidance
• Compound knowledge
• Regulatory policy and guidance
• Medical monitoring
• Safety reporting and Risk Management Plan
• CSP/CSR content, data analysis and data interpretation
• Presentation & communication skill
• Analytical and problem-solving skill
• AZ clinical development process
• Industry/competitor knowledge
• Working Experience
• Minimum 5 years of clinical development experience (at least as clinical research physician for 3 years) in pharmaceutical and/or biotech industry
• Prioritize and focus with attentive to detail and excellent analytical skill
• China development strategy and plan (including protocols) for all portfolio projects
• Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring)
• Co-owners of clinical study delivery (with Stats and Clinical Operations)
• Development documents (CIB, protocol and CSR, ETC) content owner
• Analysis and interpretation of clinical study results in partnership with BIS, Clinical Operations and Safety (as well as Clinical Pharmacologist If necessary)
• Forming and running advisory board for portfolio projects; Be responsible for interacting and communicating with China KOLs for China development strategy and protocol design
• Liaise with safety physician for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting
• Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables
• Leading the team in protocol development preparation for review by the Clinical Challenge and Protocol Review Committee
• Setting strategic direction for addressing medical issues in regulatory submission and communication/interaction
• Be a TA clinical science expert and supporting China regulatory filing and registration
• Be a TA clinical science expert and leading discussions with regulatory officials on clinical science subjects of a given compound
• Be the clinical science physician and providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators
• A core function on China Product Team representing TA Clinical Science
• Be the interface with GPT MSD/physicians on clinical sciences matters
• Provide clinical science support to BD and AZ China projects on needed base
• Liaise with MA and BD to support pre-launch marketing activities, publications, conferences and early market access to the compounds
• Maintain up-to-date medical/scientific knowledge as well as clinical trial landscape and competitive intelligences in the TA